StatusThe thesis was presented on the 15 February, 2017
Approved by NCAA on the 23 March, 2017
Abstract– 1.15 Mb / in romanian
7.24 Mb /
The dissertation is presented on 108 pages and comprises: introduction, 4 chapters, general conclusions, recommendations, bibliography from 115 sources, 54 charts, 50 figures, 10 appendixes. Keywords: Spironolactone, Phenobarbital, Captopril, hard gelatin capsules, main pharmaceutical forms, dosed powders, children, formulation, technology, quality, standardization, analytical normative documentation.
Purpose: the study of the preparation of powders for children, in order to select the most frequent prescriptions and their formulation in hard gelatin capsules in small series, and suitable for certain age categories.
Objectives of the paper: the study of drug preparation for children in the production departments of some pharmacies; biopharmaceutical and pharmacokinetic evaluation of Spironolactone, Phenobarbital, and Captopril in order to give reason for their formulation in hard gelatin capsules; research on preformulation and formulation of the capsules’ content; development of the technology of manufacturing the capsules in small series in pharmacies; adjustment of the methods of analysis and standardization for Spironolactone, Phenobarbital, and Captopril; study of stability of Spironolactone, Phenobarbital, and Captopril and determination of their shelf life; elaboration of normative analytical documents for capsules.
Novelty and scientific originality. For the first time, there were selected the most frequently encountered prescriptions for powders for children for custom medication with hard gelatin capsules. The biopharmaceutical and pharmacokinetic evaluation of Spironolactone, Phenobarbital, and Captopril based on structural-molecular properties, the studies on preformulation and formulation, on quality control and standardization, and on the composition of hard gelatin capsules with dosed powders are original, well-argued, and allow their manufacturing in small series, in pharmacies.
The Scientific problem is the elaboration of pharmaceutical forms for children in order to qualitatively supply this category of patients by implementing the technology of dosed powders in capsules and their manufacture in small series, in pharmacies. The theoretical significance of the paper resides in the systemic approach of the pharmaceutical research methods by showcasing the most frequently encountered prescriptions for children and, based on the study of active substances’ structural-molecular properties for elaboration of hard gelatin capsules with dosed powders for their manufacture in pharmacies.
The value of the work. The results of this research benefit the implementation of custom medication and completing the range of pediatric pharmaceutical forms of known medicines. The conducted studies could be used as initial support in developing the methods of,1 mgpreformulation and formulation of capsules for children and their preparation in small series in pharmacies. The dissertation is part of the scientific researches plan of SUMP “Nicolae Testemitanu”.
Practical implementation of research results. Based on the experimental results obtained, there were prepared a Temporary Pharmacopoeia Monograph: “Spironolactone capsules for children, 6 mg, 12 mg”, “Phenobarbital capsules for children, 5 mg”, “Captopril capsules for children, 1 mg, 2 mg, 3 mg”. “Technological regulations for manufacturing capsules for children in small series” that were implemented in Pharmaceutical forms department of the University Pharmaceutical Center “Vasile Procopisin” of State University of Medicine and Pharmacy “Nicolae Testemitanu” and approved by the Laboratory of Medicine Quality Control of the Medicines and Medical Devices Agency of the Ministry of Health of Republic of Moldova (Acts of implementation of 09.09. 2015). Act of implementation research rezults in Medicines and Medical Devices Agency of 11.10.2016.